Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus
Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.
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US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
Keeping Track: Enhertu Brings Anti-HER2 Therapy To Lung Cancer; Novaliq Platform Supports Two Dry Eye NDAs
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker